RE:RE:RE:Phase 0Digitel, you're trying to pass off as a logical point something that has no foundation. You're making the assumption, as you always have, that the elements of a Phase 0 project must happen serially and not concurrently.
The timeline of any project is determined by the earliest possible date that all elements of the project can be completed. No human can receive a drug in a clinical trial until the drug has been manufactured in sufficient quantities of suitable purity. Whatever time period that takes, 12, 18 or 24 months, in our case, it's likely to be the dertermining factor with respect to the earliest date that a human could be dosed.
Meanwhile (meanwhile, digitel, meanwhile!! ), after ordering up a GMP drug, and while the contractor is preparing the drug, the company can do the other prepratory work to get ready for human dosing, things such as NHP testing, biodistribution studies, pharmacokinetics, toxicity, things that may inform the design of the Phase 0/1 study. Also, the design of the clinical trial and its approval can happen while the drug is being manufactured. And maybe some grant money can be secured. These things do not form part of the critical path of the project as long as they don't take longer than the manufacturing of the drug does.
You've laid that nonsense on the forum before, digitel. Just stop. The company is not, repeat, NOT, going to be doing nothing while it waits for FP delivery. It's likely that the company will get all that other work done and will STILL be waiting for the delivery of its fusion protein.
That said, there is one element of the project that is dependent on the delivery date of the FP and that is the selection of patients. We might expect those patients (half a dozen or so, maybe) to be very sick so it's necessary for their benefit to select them only when you have the drug, or know exactly when you'll have delivery of the drug. That selection should be pretty quick and at the last moment. given the immediate needs of the patients.
Anyway, digitel, just stop making that stuff up. You should take a lesson in proper project design and management. At the very least you might learn the concept of thinking while you're writing and to complete that thinking before you post.
jdstox